a study of gnc-077 in patients with locally advanced or metastatic breast cancer and other solid tumors

Conditions: Breast Cancer; Solid Tumor

Summary: this study is an open-label, multicenter, dose-escalation and cohort expansion phase i clinical study to evaluate the safety, tolerability, pharmacokinetics characteristics or preliminary efficacy and antitumor activity in patients with locally advanced or metastatic breast cancer and other solid tumors.


Eligibility criteria:
inclusion criteria: 1. able to understand the informed consent form, voluntarily participate in and sign the informed consent form; 2. gender is not limited; 3. age: ≥18 years old and ≤75 years old (stage ia); ≥18 years old (stage ib); 4. locally advanced or metastatic breast cancer and other solid tumors; 5. must have at least one measurable lesion that meets the recist v1.1 definition; 6. have archived primary or recurrent tumor tissue specimens that can be submitted for central review; 7. ecog ≤1; 8. the expected survival time as judged by the investigators was ≥3 months; 9. bone marrow function, renal function and liver function should meet the requirements; 10. coagulation function: fibrinogen ≥1.5g/l; activated partial thromboplastin time (aptt) ≤1.5×uln; prothrombin time (pt) ≤1.5×uln; 11. fertile female subjects or male subjects with fertile partners must use highly effective contraception from 7 days before the first dose until 12 weeks after the last dose. female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose; 12. subjects were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures. exclusion criteria: 1. chemotherapy, biological therapy, immunotherapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; mitomycin and nitrosoureas were administered within 6 weeks before the first dose; oral drugs such as fluorouracil; 2. patients with active infection requiring intravenous antibiotics who did not complete treatment within 1 week before enrollment, except prophylactic antibiotics for puncture or biopsy; 3. positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis b virus infection or hepatitis c virus infection; 4. no reduction in toxicity from previous antineoplastic therapy to grade i as defined in ctcae, version 5.0, or to the level specified in the inclusion criteria; 5. patients at risk for active autoimmune disease or with a history of autoimmune disease may have central nervous system involvement; 6. pulmonary disease defined as ≥ grade 3 according to nci-ctcae v5.0; a history of ild requiring steroid therapy, or current ild or grade ≥2 radiation pneumonitis; 7. patients with previous allogeneic hematopoietic stem cell transplantation or organ transplantation; 8. had a history of severe cardiovascular and cerebrovascular diseases; 9. patients had or had thrombotic events such as deep vein thrombosis, arterial thrombosis and pulmonary embolism within 6 months before screening; 10. brain parenchymal metastases and/or meningeal metastases or spinal cord compression, excluding stable and asymptomatic brain parenchymal metastases; 11. uncontrolled pleural effusion with clinical symptoms who were judged by the investigator to be ineligible for enrollment; 12. poorly controlled hypertension (systolic blood pressure \&gt; 150 mmhg or diastolic blood pressure \&gt; 100 mmhg); 13. who had participated in a clinical trial of an unmarketed drug within 4 weeks before the study dose (counted as the end of the last dose); 14. had received a live vaccine within 4 weeks before the trial dose; 15. other circumstances that the investigator deemed inappropriate for participation in the trial.